An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDT2980S in Combination with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma
This phase 1 study is the first time that DCDT2980S (the study drug) is administered to humans and more specifically patients with blood cancers. Laboratory tests have shown a decrease in cancer cell growth. The purpose of this study is to test the safety, tolerability, and anti-tumor activity of the study drug, at varying strengths, in subjects with Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).
There are three stages to this study, subjects will be assigned to one of the following three stages: dose escalation, expansion, or combination of study drug and rituxan
Subjects with CLL and NHL expected to express CD22 antigen for which no standard therapy exists.
Excluding subjects that have a allogenic stem cell transplant previously, a history of other malignancy, or central nervous system lymphoma.
18 - 99
Healthy Volunteers Needed
Duration of Participation
Until disease progression, unacceptable toxicity, voluntary subject withdrawal or investigator discretion; follow-up for one year.
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